Australia TGA ARTG record

Bone-screw internal spinal fixation system, non-sterile

Australia TGA ARTG Registered Device · Life Healthcare Pty Ltd · SMAIO · Class IIb · Started April 21, 2021

Good Name: Life Healthcare Pty Ltd - Bone-screw internal spinal fixation system, non-sterile

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 21, 2021
Effective Date: April 21, 2021

Sponsor

Name: Life Healthcare Pty Ltd

Manufacturer

Name: SMAIO
Country: France
Address: 2 Place Berthe Morisot, Parc Technologique, SAINT PRIEST, 69800

Intended purpose

a spinal fixation system intended to help provide immobilisation and stabilisation of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

About this record

Access comprehensive regulatory information for Bone-screw internal spinal fixation system, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Life Healthcare Pty Ltd, manufactured by SMAIO in France. The device registration started on April 21, 2021.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.